Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial

NCT ID: NCT06990893

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2026-10-01

Brief Summary

Objective: To compare the application of oxelidine in postoperative analgesia after orthopedic lumbar spine surgery with morphine or sufentanil, and to explore the efficacy and safety of postoperative analgesia.

Method: Researchers included 90 patients with American Society of Anesthesiologists (ASA) physical conditions I and III, aged 18 to 65 years, who were scheduled to undergo orthopedic lumbar general anesthesia surgery at an appropriate time. The patients were randomly divided into 3 groups, with 30 cases in each group: The oxeridine group (Group A), where a loading dose of 1.5mg of oxeridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01mg/kg-1.h-1 was connected. Oxeridine was mixed with normal saline to 100ml at a rate of 2ml/h. Morphine group (Group M), a loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03mg.kg-1.h-1 morphine was connected with normal saline to 100ml at a rate of 2ml/h. Sufentanil group (Group S), a 4u loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was combined with normal saline to 100ml at a rate of 2ml/h.The resting and exercise VAS pain scores of the three groups of patients at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation and adverse reactions within 48 hours were recorded.

Conditions

Sufentanil; Morphine; Validity; Safety; Oliceridine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

The oliceridine group(A)

A loading dose of 1.5mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 orselidine was connected and diluted with normal saline to 100ml at a rate of 2ml per hour

Group Type: EXPERIMENTAL

Oliceridine

Intervention Type: DRUG

a loading dose of 1.5 mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 oliceridine was connected with normal saline to 100 ml at a rate of 2 ml per hour

The morphine group(M)

A loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump was connected to 0.03mg.kg-1.h-1 morphine mixed with normal saline to 100ml at a rate of 2ml per hour

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

a loading dose of 4 mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 mg.kg-1.h-1 morphine was connected with normal saline to 100 ml at a rate of 2 ml per hour

The sufentanil group(S)

A loading dose of 4ug of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was mixed with normal saline to 100ml at a rate of 2ml per hour

Group Type: EXPERIMENTAL

Sufentanil

Intervention Type: DRUG

A 4 ug loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 ug.kg-1 h-1 was connected. sufentanil was mixed with normal saline to 100 ml at a rate of 2 ml per hour

Interventions

Oliceridine

a loading dose of 1.5 mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 oliceridine was connected with normal saline to 100 ml at a rate of 2 ml per hour

Intervention Type: DRUG

Morphine

a loading dose of 4 mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 mg.kg-1.h-1 morphine was connected with normal saline to 100 ml at a rate of 2 ml per hour

Intervention Type: DRUG

Sufentanil

A 4 ug loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 ug.kg-1 h-1 was connected. sufentanil was mixed with normal saline to 100 ml at a rate of 2 ml per hour

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Lumbar spine surgery with ASA grades I-III
• Aged 18-65 years
• Ethically, the patient voluntarily accepted this trial and signed the informed consent form

Exclusion Criteria

• Severe respiratory and circulatory system diseases
• Nervous system disease
• Mental and psychological disorders
• Abnormal liver and kidney functions
• Participated in another drug clinical research within the past 30 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anqing Municipal Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sun Ling Lu Sun Ling LU, Master's degree

Role: CONTACT

348092640@qq.com

15955565806

Other Identifiers

Sun Ling

Identifier Type: -

Identifier Source: org_study_id